# K955299: DPS 4 Dialyzer Preparation System

- Pathway: 510(k) (Traditional)
- Applicant: Seratronics, Inc.
- Decided: Oct 21, 1996 after 336 days
- Product code: LIF (Dialyzer Reprocessing System)
- Device class: 2
- Regulation: 21 CFR 876.5820
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K832230 (1983). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K832230: Dialyzer Preparation Sys DPS-4, Seratronics, Inc. (1983) Summary page 2.
- (no number) dialysis machine: named in the summary without a submission number

## Indications for use
This device is intended solely for processing (e.g., in vitro rinsing) of hemodialyzers. Any subsequent clinical use of the dialyzer processed by this machine is sole responsibility of the patient's physician.

Source page: https://510kreport.com/device/K955299
Methodology: https://510kreport.com/methodology